Indications and uses
temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose nasal and sinus congestion sneezing sore throat temporarily reduces fever
temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose nasal and sinus congestion sneezing sore throat temporarily reduces fever
adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use
each tablet contains: sodium 474 mg Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet store at room temperature. Avoid excessive heat.
Drug Facts
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Aspirin may cause a severe allergic reaction which may include:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children.
Do not use
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate
1-800-986-0369 (Mon-Fri 9AM – 5PM EST)
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70264-015-01 | 2022-12-30 | C162847 | 48780-1 | 9d75b9d0-e6f8-f424-e053-dadaa90a57ce | Alka-Seltzer Plus ® Cold Medicine Sparkling Original |
| 70264-015-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e6f8-f424-e053-dadaa90a57ce | Alka-Seltzer Plus ® Cold Medicine Sparkling Original |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-1400-36 | EA - Each | 0280-1400 | d9ce5ae8-6625-47f9-ad92-12f7edef8e05 | 1 | 2018-12-13 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70264-015 | 70264-015-01 |
| 0280-1400 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| CALCIUM SILICATE | S4255P4G5M | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Cold Medicine Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 78537dcf-b157-4b67-a8b2-5cb144815166 | 2025-12-04 | Warnings | 0280-1400 |
| f00103df-63f2-2379-e053-2a95a90a7168 | 92111477-9137-416e-b1c0-293e5a855123 | 2022-12-17 | Warnings | 92111477-9137-416e-b1c0-293e5a855123 |
Adverse event summaries are temporarily unavailable. Other product information remains available.